Recruiting

Maternal Health

Sponsor:

UCLA

Code:

NCT06340152

Conditions

Pre-Eclampsia

Pregnancy Induced Hypertension

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Study Details

Brief summary:

To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.

Conditions

Pre-Eclampsia

Pregnancy Induced Hypertension

Study ID

NCT06340152

Start date

Dec 20, 2023

Status verified date

Apr, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant women 18 years of age to 50 years of age
  • 10-24 weeks gestation at time of enrollment
  • Singleton pregnancy
  • Planning to deliver at a study site (UCSD or VUMC)

Exclusion Criteria:

  • Inability to give informed consent
  • Intrauterine fetal demise
  • Fetal genetic or structural anomaly
  • Institutionalization for psychiatric disorder, mental deficiency or incarcerated
  • Active or history of malignancy requiring major surgery or systemic chemotherapy
  • Multi-fetal gestation or a twin demise at any gestational age
  • Known maternal or fetal chromosomal anomalies
  • Patients who plan to keep their placenta after delivery

Study Design

Enrollment

1100 participants

Anticipated

Interventions and Outcome Measures

Arms

Low-risk pregnancy

Pregnant subjects with none of the following: chronic hypertension, pregestational diabetes, renal disease, autoimmune disease, history of preterm preeclampsia in a prior pregnancy

High-risk pregnancy

Pregnant subjects with one or more of the following: chronic hypertension, pregestational diabetes, renal disease, autoimmune disease, history of preterm preeclampsia in a prior pregnancy

Primary outcome measure

  • Preeclampsia [ Time Frame: 2nd trimester - 13 months postpartum ]
  • Gestational hypertension [ Time Frame: 2nd trimester - Delivery ]
  • Postpartum hypertension [ Time Frame: Delivery - 13 months postpartum ]

Central Contacts and Locations

Central contacts

Maya Selvaraj

858-249-5985momhealthstudy@health.ucsd.edu

Valentina Stanley

858-249-5985

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Maya Selvaraj

858-776-8374mlselvaraj@health.ucsd.edu

Principal Investigator:

Louise Laurent, MD, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 6, 2025

Last verified

Apr, 2025

Keywords

  • hypertension
  • pregnancy
  • pre-eclampsia
  • postpartum

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-04-06.